Orange Book product · Brand (NDA)
WESTCORT
HYDROCORTISONE VALERATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROCORTISONE VALERATE
Strength
0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 017950
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1983WESTCORTBrand (NDA)
NDA 018726 · SUN PHARM INDS INC
- 2021HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211047 · ENCUBE ETHICALS
- 2021HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 213724 · COSETTE PHARMS NC
- 2020HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211764 · COSETTE PHARMS NC
- 2019HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 210307 · LUPIN
- 2018HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211750 · GLENMARK PHARMS LTD
- 2018HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211129 · GLENMARK PHARMS LTD
- 2001HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075085 · FOUGERA PHARMS
- 2000HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075666 · PADAGIS ISRAEL
- 1998HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075042 · SUN PHARMA CANADA
- 1998HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075043 · SUN PHARMA CANADA
- 1998HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 074489 · COSETTE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
